Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05135494
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2021-11-10
Brief Title:
Effects of Inspiratory Muscle Training on the Severity of Obstructive Sleep Apnea in Individuals After Stroke
Sponsor:
Sarah Network of Rehabilitation Hospitals
Organization:
Sarah Network of Rehabilitation Hospitals
Study Overview
Official Title:
Effects of Inspiratory Muscle Training on the Severity of Obstructive Sleep Apnea in Individuals After Stroke a Randomized and Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of Obstructive Sleep Apnea OSA is high in individuals after a stroke There are few studies evaluating the effects of inspiratory muscle training IMT in individuals with OSA and the findings regarding the possible effect on ApneiaHipopneia Index AHI reduction are still controversial
This study will test the hypothesis that training of the inspiratory muscles is effective in improving severity of OSA sleep quality and daytime sleepiness in individuals after stroke participating in a rehabilitation program
Methods For this prospective sigle blinded randomized clinical trial people after stroke will be randomly allocated into either experimental or control groups The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75 of the subjects maximal inspiratory pressure MIP values five timesweek over five weeks 5 sets of 5 repetitions with 1 set increasing each week Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy speech therapy and aerobic exercise sessions At baseline and post intervention after the cessation of the interventions researchers blinded to group allocations will collect all outcome measures
Study outcomes Primary outcome will be OSA severity measured using the ApneaHypopnea Index AHI Secondary outcomes will include inspiratory endurance and pressure functional independence sleep quality and daytime sleepiness
This study will test the hypothesis that training of the inspiratory muscles is effective in improving severity of OSA sleep quality and daytime sleepiness in individuals after stroke participating in a rehabilitation program
Methods For this prospective sigle blinded randomized clinical trial people after stroke will be randomly allocated into either experimental or control groups The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75 of the subjects maximal inspiratory pressure MIP values five timesweek over five weeks 5 sets of 5 repetitions with 1 set increasing each week Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy speech therapy and aerobic exercise sessions At baseline and post intervention after the cessation of the interventions researchers blinded to group allocations will collect all outcome measures
Study outcomes Primary outcome will be OSA severity measured using the ApneaHypopnea Index AHI Secondary outcomes will include inspiratory endurance and pressure functional independence sleep quality and daytime sleepiness
Detailed Description:
The prevalence of Obstructive Sleep Apnea OSA is high in individuals after a stroke The gold standard treatment for OSA is the use of Positive Airway Pressure but due to the low adherence to this resource the multidisciplinary approach for the treatment of OSA is becoming the best therapeutic option There are few studies evaluating the effects of inspiratory muscle training IMT in individuals with OSA and the findings regarding the possible effect on ApneiaHipopneia Index AHI reduction are still controversial
AimsThe primary objective of this study is to identify the effects of IMT on the severity of OSA in indivuals after stroke participating in a rehabilitation program The secondary objectives are to identify effects of IMT on sleep quality and daytime sleepiness and analyze the correlation between severity of OSA and functional independence inspiratory endurance and pressure
Methods For this prospective sigle blinded randomized clinical trial people after stroke will be randomly allocated into either experimental or control groups The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75 of the subjects maximal inspiratory pressure MIP values five timesweek over five weeks 5 sets of 5 repetitions with 1 set increasing each week Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy speech therapy and aerobic exercise sessions At baseline and post intervention after the cessation of the interventions researchers blinded to group allocations will collect all outcome measures
Study outcomes Primary outcome will be OSA severity measured using the ApneaHypopnea Index AHI Secondary outcomes will include inspiratory endurance and pressure functional independence sleep quality and daytime sleepiness
AimsThe primary objective of this study is to identify the effects of IMT on the severity of OSA in indivuals after stroke participating in a rehabilitation program The secondary objectives are to identify effects of IMT on sleep quality and daytime sleepiness and analyze the correlation between severity of OSA and functional independence inspiratory endurance and pressure
Methods For this prospective sigle blinded randomized clinical trial people after stroke will be randomly allocated into either experimental or control groups The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75 of the subjects maximal inspiratory pressure MIP values five timesweek over five weeks 5 sets of 5 repetitions with 1 set increasing each week Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy speech therapy and aerobic exercise sessions At baseline and post intervention after the cessation of the interventions researchers blinded to group allocations will collect all outcome measures
Study outcomes Primary outcome will be OSA severity measured using the ApneaHypopnea Index AHI Secondary outcomes will include inspiratory endurance and pressure functional independence sleep quality and daytime sleepiness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None